Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Topic	Advisory Committee	Date
Appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use	Bone, Reproductive & Urologic Drugs and Drug Safety/Risk Management	Sept. 17
Clarus Therapeutics’ oral testosterone undecanoate tablets for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired)	Bone, Reproductive & Urologic Drugs and Drug Safety/Risk Management	Sept. 18
Updates on research programs in the CDER Division of Therapeutic Proteins’ Laboratory of Biochemistry, and the Division of Monoclonal Antibodies’ Laboratory of Molecular Oncology and Laboratory of Molecular and Developmental Immunology (open session); intramural research program reports and recommendations on personnel staffing decisions (closed session)	Cellular, Tissue & Gene Therapies	Sept. 18 (teleconference)
Pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act, for various products	Pediatric	Sept. 23
Safety data from observational studies and a meta-analysis of randomized controlled clinical trials that have been conducted since the original signal of serious neuropsychiatric adverse events with Pfizer’s Chantix (varenicline) emerged, and whether any action needs to be taken with regard to how this risk is described in product labeling	Psychopharmacologic Drugs and Drug Safety/Risk Management	Oct. 16
Novartis’ secukinumab for treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy	Dermatologic & Ophthalmic Drugs	Oct. 20
Daiichi Sankyo’s edoxaban for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation	Cardiovascular & Renal Drugs	Oct. 30
Draft guidance for industry entitled “Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products,” and the Dear Gene Therapy IND or Master File Sponsor Letter	Cellular, Tissue and Gene Therapies	Nov. 6